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Compositions and methods for treating heart failure in diabetic patients

a technology for diabetic patients and compositions, applied in the field of compositions and methods for treating heart failure in diabetic patients, can solve the problems of impaired calcium handling in diabetic patients, impaired renin-angiotensin system, and marked increase in the risk of coronary artery disease in dm

Active Publication Date: 2021-01-19
ZENSUN (SHANGHAI) SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent describes a discovery that neuregulin can benefit heart failure patients, particularly those who are diabetic. Neuregulin improves heart muscle cell differentiation, promotes cell adhesion, and protects against heart failure. It can be administered as a pharmaceutical composition to chronic heart failure patients, with intravenous or subcutaneous administration. The treatment can involve a continuous introduction or a maintenance regimen. The technical effect is that neuregulin improves cardiac function and structure, reducing mortality and improving survival in diabetic heart failure patients.

Problems solved by technology

DM is associated with a markedly increased risk of coronary artery disease which is the underlying cause of HF.
It may be resulted from impaired calcium handling in diabetic patients.
Otherwise, the renin-angiotensin system is unregulated with diabetes, and Angiotensin II (Mg II) locally may lead to oxidative damage, activating cardiac cell death.
Apoptosis and necrosis of myocytes may contribute to the development of a dilated myopathy which may result in heart failure.
Targeted disruption of the NRG-1β or ErbB2 or ErbB4 led to embryonic lethality due to cardiac development defects.

Method used

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  • Compositions and methods for treating heart failure in diabetic patients

Examples

Experimental program
Comparison scheme
Effect test

example 1

The Effect of Neucardin™ Administration by Different Routes on the Survival Rate of Rats with CHF

[0052]Introduction

[0053]In this study, we used a coronary artery ligation (CAL) model mimicking the myocardial infarction in the diabetic patients to investigate whether administration of Neucardin™ by IV drip using a by micro-injection pump or by subcutaneous (SC) bolus had any effects on survival rate and cardiac hemodynamics, 120 days after the initiation of administration of Neucardin™ 4 weeks after CAL. Echocardiography and cardiac remodeling were also used to determine cardiac function and recovery from CAL.

[0054]2. Methods:

[0055]2.1. Test Animals:

[0056]Strain, Origin: Wistar rats, Shanghai SLAC Laboratory Animal CO. LTD; Weight, 200±10 g, male;

[0057]2.2 Test Article:

[0058]2.2.1 Neucardin™

[0059]Identification: Recombinant human neuregulin-1 for injection (rhNRG-1, Neucardin™)

[0060]Lot Number: 200607009

[0061]Manufacturer: Zensun (Shanghai) Sci & Tech Co., Ltd

[0062]Dose form: Lyophil...

example 2

A Randomized, Double-Blinded, Multi-Center, Placebo Controlled Study to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin 1 in Patients with Chronic Heart Failure Based on Standard Treatment

[0100]To evaluate the efficacy of recombinant human neuregulin-1 for injection on chronic heart failure including those diabetic patients with chronic heart failure, a phase II, double-blinded, multi-center, placebo controlled, standard treatment based study was carried out in multiple clinical centers in China. A total of 195 patients with NYHA Class II or III stable chronic heart failure including 21 diabetic patients were enrolled and randomized into three groups: placebo, or 0.6 μg / kg and 1.2 μg / kg of rhNRG-1. There were 13 patients with diabetic in Neucardin group (5 in 0.6 μg / kg / day arm and 8 in 1.2 μg / kg / day arm), and 9 patients in placebo group. There were no significant variations in demographics or background therapies among groups. According to the schedule, patients wer...

example 3

A Randomized, Double-Blinded, Multi-Center, Placebo Controlled Survival Study of Recombinant Human Neuregulin 1 in Patients with Chronic Heart Failure Based on Standard Treatment

[0114]To evaluate the efficacy of recombinant human neuregulin-1 for injection on chronic heart failure including those diabetic patients with chronic heart failure, a phase II, double-blinded, multi-center, placebo controlled, standard treatment based study was carried out in multiple clinical centers in China. A total of 351 patients with NYHA Class III or IV stable chronic heart failure were enrolled and randomized into placebo group or rhNRG-1 group (0.6 μg / kg). 68 of 351 patients were diabetic patients, with 35 cases in placebo group, and 33 cases in Neucardin™ group. There were no significant variations in demographics or background therapies among groups. According to the schedule, patients were administered with the drug for 10 consecutive days in the hospital, after finishing the day 11 follow up, t...

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Abstract

The present invention provides the use of neuregulin protein for the preparation of medication for preventing, treating or delaying heart failure in humans and methods for preventing, treating or delaying heart failure in humans using said medication.

Description

[0001]This application is a U.S. national stage application of PCT / CN2012 / 001353, having an international filing date of Oct. 8, 2012, the entire contents of which are incorporated herein by reference.[0002]Incorporated herein by reference is the Sequence Listing being concurrently submitted via EFS-Web as an ASCII text file named 11748-048-999_Sequence_Listing.txt, created Mar. 19, 2015, and being 851 bytes in size.FIELD OF THE INVENTION[0003]The present invention relates to the use of neuregulin protein for the preparation of medication for preventing, treating or delaying heart failure in humans and methods for preventing, treating or delaying heart failure in humans using said medication. Particularly, the present invention provides methods for preventing, treating or delaying heart failure using the composition comprising a neuregulin protein in diabetic patients who has had or at high risk of a complication of heart diseases.BACKGROUND OF THE INVENTION[0004]Over recent years, ...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61K38/16A61K38/18C07K14/475
CPCC07K14/4756A61K38/1883C13K13/002C13K13/007A61P9/00A61P9/04A61P9/10A61P3/10A61K38/18
Inventor ZHOU, MINGDONG
Owner ZENSUN (SHANGHAI) SCI & TECH CO LTD
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